BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31X8 100 PK GERMANY

    MDR report key: 8670238 · Received June 5, 2019

    Report

    Report Number
    9616656-2019-00508
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS OF A 31G X 8MM PEN NEEDLE SAMPLE WERE RETURNED FROM LOT. NO. 8143587, CAT. NO. 325105. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND A CANNULA THROUGH SHIELD AND COVER WAS OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA131809 WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE PN 31X8 100 PK GERMANY THE NEEDLE TIP WAS STICKING OUT OF THE PACKAGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "A CUSTOMER BROUGHT US A PENNADEL STILL PACKED IN THE APPROPRIATE ENVELOPE BACK TO THE PHARMACY, AS THE NEEDLE TIP LATERALLY STICK OUT OF THE PLASTIC. DUE TO THE RISK OF INJURY, I WANT THE REPORT THIS INCIDENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE PN 31X8 100 PK (B)(6) THE NEEDLE TIP WAS STICKING OUT OF THE PACKAGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A CUSTOMER BROUGHT US A PENNADEL STILL PACKED IN THE APPROPRIATE ENVELOPE BACK TO THE PHARMACY, AS THE NEEDLE TIP LATERALLY STICK OUT OF THE PLASTIC. DUE TO THE RISK OF INJURY, I WANT THE REPORT THIS INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465423 PN 31X8 100 PK GERMANY PEN NEEDLE FMI BECTON DICKINSON AND CO. 8143587

    Patients

    Seq Age Sex Outcome Treatment
    1 Other